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Chronic InsomniaPhase 3NCT00247390

Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

A Phase 3 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 48 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Insomnia
What is being tested?
Ramelteon
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
451 participants
Where
48 sitesin 9 countries
Study dates
Jul 2005to Dec 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Body mass index between 18 and 34, inclusive.
  • Based on sleep history, has had chronic insomnia for at least 3 months.
  • Based on sleep history, reports a subjective sleep latency greater than or equal to 45 min and a subjective total sleep time less than or equal to 6.5 hours.
  • Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM.
  • Mean latency to persistent sleep of greater than 20 minutes on two consecutive screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes.
  • Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months.

Who cannot join

  • Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.
  • Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.
  • Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication.
  • Flown across greater than three time zones within 7 days prior to or during screening.
  • Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of single-blind study medication.
  • Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia.
Show all 43Show fewer
  • History of psychiatric disorder within the past 6 months.
  • History of alcohol abuse within the past 12 months, as defined in Diagnostic \& Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week, or consumed any alcoholic drinks within 24 hours of any polysomnogram visits.
  • History of drug abuse within the past 12 months, as defined in Diagnostic \& Statistical Manual of Mental Disorders, 4th Edition Revised.
  • Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication.
  • Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night.
  • Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night.
  • Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits.
  • Positive breathalyzer test on any of the polysomnogram assessment visits.
  • Uses tobacco products (including nicotine gum and patch) or any other products that may interfere with the sleep wake cycle during nightly awakenings.
  • Used any central nervous system medication or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the administration of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
  • Intends to continue taking any disallowed medication or any prescription medication or over the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication. The subject must report all prescription and over the counter medications taken in the three weeks prior to screening.
  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
  • Anxiolytics
  • Sedatives
  • Hypnotics
  • CNS active drugs (including herbal)
  • Antidepressants
  • Narcotic analgesics
  • Anticonvulsants
  • Beta blockers
  • Sedating H1 antihistamines
  • St. John's Wort
  • Systemic steroids
  • Kava-kava
  • Respiratory stimulants
  • Ginkgo-biloba
  • Decongestants
  • Over-the-counter and prescription stimulants
  • Antipsychotics
  • Over-the-counter and prescription diet aids
  • Muscle Relaxants
  • Melatonin and all other drugs or supplements known to affect sleep/wake function
  • Any additional condition(s) that in the Investigator's opinion would
  • affect sleep/wake function
  • prohibit the subject from completing the study
  • indicate that continuation in the study would not be in the best interests of the subject.
  • History of hepatitis B or hepatitis C.

Trial locations and contacts

48 sites in 9 countries.

48 sites in 9 countries

United States19 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Birmingham, Alabama

  • Study site

    Chevy Chase, Maryland

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Hot Springs, Arkansas

  • Study site

    Lincoln, Nebraska

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Miami, Florida

  • Study site

    Naples, Florida

  • Study site

    New York, New York

  • Study site

    Oakland, California

  • Study site

    Overland Park, Kansas

  • Study site

    San Diego, California

  • Study site

    Santa Monica, California

  • Study site

    Toledo, Ohio

  • Study site

    Winter Park, Florida

Other trials in United States

Germany6 sites

  • Study site

    Berlin

  • Study site

    Göttingen

  • Study site

    Hamburg

  • Study site

    Münster

  • Study site

    Schwalmstadt

  • Study site

    Schwerin

Other trials in Germany

France5 sites

  • Study site

    Bron

  • Study site

    Clamart

  • Study site

    Garches

  • Study site

    Paris

  • Study site

    Rouffach

Other trials in France

Russia5 sites

  • Study site

    Irkutsk

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Yekateringburg

Other trials in Russia

Australia4 sites

  • Study site

    Adelaide

  • Study site

    Camperdown

  • Study site

    Melbourne

  • Study site

    Victoria

Other trials in Australia

Czechia3 sites

  • Study site

    České Budějovice

  • Study site

    Ostrava-Poruba

  • Study site

    Prague

Other trials in Czechia

Finland3 sites

  • Study site

    Espoo

  • Study site

    Helsinki

  • Study site

    Turku

Other trials in Finland

Belgium2 sites

  • Study site

    Brussels

  • Study site

    Edegem

Other trials in Belgium

Italy1 site

  • Study site

    Milan

Other trials in Italy

About this study

Official title: A Randomised, Double-blind, Placebo-controlled Study to Determine the Long-term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).

Read the detailed description

A vast majority of people are affected by chronic insomnia in the western world. Several studies have looked at this and have estimated that 30% to 48% of the general population is affected at some time in their life with a form of insomnia that goes on for several months, and about one third of those are described as severely affected. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related conditions that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.

An ideal treatment for chronic insomnia would include administration of therapy for an extended period. Specifically, it should be safe and effective for a period longer than the 7 to 10 days to which use of the current drugs approved for short-term use are limited.

Because of the absence of evidence of residual effects in pre-clinical studies and phase 2 and 3 clinical trials, ramelteon may be a candidate for extended use. As chronic insomnia becomes more prevalent, there is a need to assess the long-term efficacy and safety of nightly dosing with ramelteon in the general population. Study participation is anticipated to be about 8 months and 3 weeks.

Being tested
Ramelteon, Placebo
Keywords
Chronic Insomnia, Sleep Initiation and Maintenance Disorder, Drug Therapy
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamelteonDrug

    Also called Rozerem, TAK-375

    Ramelteon 8 mg, tablets, orally, once daily for up to 42 weeks.

  • PlaceboDrug

    Ramelteon placebo-matching tablets, orally, once daily for up to 42 weeks.

Study groups in NCT00247390
Study groupRoleWhat they receive
Ramelteon 8 mg QDExperimentalNot described
Receives: Drug: Ramelteon
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in Latency to Persistent Sleep of 2-night polysomnogram.

    Measured: Months 3 and 6 or Final Visit

Secondary outcomes (11)

  1. Mean change in Total Sleep Time from polysomnogram, on 2 nights over 6 months.

    Measured: Week 1 and Months 1, 3, 5 and 6 or Final Visit

  2. Mean change in Subjective Sleep Latency by postsleep questionnaire on 2 nights over 6 months.

    Measured: Week 1 and Months 1, 3, 5 and 6 or Final Visit

  3. Mean change in Subjective Total Sleep Time by postsleep questionnaire on 2 nights over 6 months.

    Measured: Week 1 and Months 1, 3, 5 and 6 or Final Visit

  4. Mean change in Subjective Number of Awakenings by postsleep questionnaire.

    Measured: Week 1 and Months 1, 3, 5 and 6 or Final Visit

  5. Mean change in Subjective Sleep Quality by postsleep questionnaire.

    Measured: Week 1 and Months 1, 3, 5 and 6 or Final Visit

  6. Total Sleep Time in rapid eye movement (REM) sleep as determined by polysomnogram.

    Measured: Week 1 and Months 1, 3, 5 and 6 or Final Visit

  7. Total Sleep Time in stage 1 non-rapid eye movement (NREM) sleep as determined by polysomnogram.

    Measured: Week 1 and Months 1, 3, 5 and 6 or Final Visit

  8. Total Sleep Time in stage 2 non-rapid eye movement (NREM) sleep as determined by polysomnogram.

    Measured: Week 1 and Months 1, 3, 5 and 6 or Final Visit

  9. Total Sleep Time in stage 3/4 non-rapid eye movement (NREM) sleep as determined by polysomnogram.

    Measured: Week 1 and Months 1, 3, 5 and 6 or Final Visit

  10. Total Sleep Time in stage 1 sleep as determined by polysomnogram.

    Measured: Week 1 and Months 1, 3, 5 and 6 or Final Visit

  11. Latency to Rapid Eye Movement as determined by polysomnogram.

    Measured: Week 1 and Months 1, 3, 5 and 6 or Final Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionDec 2006
  4. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00247390
Sponsor's protocol ID
TAK-375-EC302
Other IDs
2004-004351-20, U1111-1114-3231, 2004
Status last verified
Jun 2010
First submitted
28 Oct 2005
Last updated
3 Jun 2010
Results posted
No
Data monitoring committee
No

Publications

  • Mayer G, Wang-Weigand S, Roth-Schechter B, Lehmann R, Staner C, Partinen M. Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia. Sleep. 2009 Mar;32(3):351-60. doi: 10.1093/sleep/32.3.351.

    PubMed 19294955

  • Wang-Weigand S, McCue M, Ogrinc F, Mini L. Effects of ramelteon 8 mg on objective sleep latency in adults with chronic insomnia on nights 1 and 2: pooled analysis. Curr Med Res Opin. 2009 May;25(5):1209-13. doi: 10.1185/03007990902858527.

    PubMed 19327100

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 48 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Germany, France, Russia, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in Latency to Persistent Sleep of 2-night polysomnogram. (time frame: Months 3 and 6 or Final Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00247390, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2010.

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